A Study Comparing Two Magnetic Resonance Imaging (MRI) Contrast Agents in MRI of the Brain (ENHANCE)

January 18, 2008 updated by: Bracco Diagnostics, Inc

Phase IV, Double-Blind, Multi-Center, Randomized, Cross-Over Study to Compare 0.10 Mmol/kg of MultiHance With 0.10 Omniscan in Magnetic Resonance Imaging (MRI) of the Brain

This study aims at a direct comparison between Multihance and a validated comparator like Omniscan in a cross-over individual design in patients with brain tumors to confirm the superior overall diagnostic performance of MuliHance for this indication

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

114

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Bracco Diagnostics, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 yrs of age or older; provide written informed consent; scheduled to undergo MRI; willing to undergo 2 MRI exams within 14 days

Exclusion Criteria:

  • Known allergy to one or more ingredients in the test agents; severe CHF (Class IV); suffered stroke one year ago; pregnancy or lactating females; contraindications to MRI; severe claustrophobia; scheduled to receive surgery prior to or between the two MRI exams, or steroids or radiosurgery between the two MRI exams

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Superiority of Multihance in terms of by-patient global diagnostic performance
Time Frame: immediately post dose
immediately post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare the two products in terms of by patients global performance for border delineation of lesions; contrast of lesions
Time Frame: immediately post dose
immediately post dose
To compare the two products in terms of global changes in lesion count; To compare the two products in terms of changes from pre to post dose in signal intensity
Time Frame: immediately post dose
immediately post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bracco Diagnostics, Inc

Investigators

  • Study Director: Barry Hogstrom, M. D., Bracco Diagnostics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

May 5, 2006

First Submitted That Met QC Criteria

May 5, 2006

First Posted (Estimate)

May 9, 2006

Study Record Updates

Last Update Posted (Estimate)

January 23, 2008

Last Update Submitted That Met QC Criteria

January 18, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • MH 130

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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